CAMBRIDGE, Mass., April 20, 2015 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today presented new data from studies conducted as part of the ANDA submission for once daily Glatopa (glatiramer acetate injection) at the 67th American Academy of Neurology (AAN) Annual Meeting in Washington D.C. The posters presented provide examples of a selection of methods the Company utilized to show the equivalence of Glatopa and once daily COPAXONE 20 mg.
Momenta Presentation Highlights:
Poster #P1.144 – Comparative Gene Expression Profiling between a Generic (Glatopa) and Brand COPAXONE (glatiramer acetate injection)
- Microarray analysis across the entire genome was performed in murine glatiramer acetate-responsive Th2-polarized T cells, a test system highly relevant to the biology of glatiramer acetate. Multiple statistical methods consistently demonstrated assay sensitivity as well as equivalent gene expression profiles between Glatopa and Copaxone.
Poster #P1.145 – Demonstration of Equivalence between a Generic (Glatopa) and Brand COPAXONE (glatiramer acetate injection)
- This poster summarized Momenta's overall approach of comparison, as well as multiple examples of equivalence of starting materials and basic chemistry; equivalence of structural manufacturing process signatures; equivalence of physicochemical (structural) properties; and equivalence of biological/immunological (functional) properties.
The selected assays and data presented at AAN are examples of the extensive physicochemical methods and biological/immunological assays that were submitted to the FDA as part of the recently approved data package for Glatopa.
"These posters not only provide examples of the comprehensive program we conducted to evaluate the equivalence of Glatopa and daily COPAXONE 20 mg, these data also further validate Momenta's ability to deeply characterize complex drugs and disease biologies and develop high-quality drugs," said Ganesh V. Kaundinya, Chief Scientific Officer of Momenta Pharmaceuticals.
Once daily Glatopa (glatiramer acetate injection), developed in collaboration with Sandoz, is the first FDA-approved generic version of daily COPAXONE® 20 mg for patients with relapsing forms of multiple sclerosis. Produced entirely in the United States, once daily Glatopa has been determined by the FDA to be therapeutically equivalent to daily COPAXONE 20 mg, and is an "AP" rated, fully-substitutable product. As a therapeutically equivalent generic product, once daily Glatopa contains the same active ingredients, route of administration, strength, and dosage form, and can be substituted with the full expectation that Glatopa will produce the same clinical effect and safety profile as daily COPAXONE 20 mg. Daily COPAXONE 20 mg is one of the leading products marketed to treat multiple sclerosis, and is frequently prescribed as a first-line therapy in newly diagnosed patients.
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural and functional analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications.
To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release. The company's logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.
Forward Looking Statements
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to its beliefs and intentions related to the marketing approval, launch and commercialization of our Glatopa product, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "hope," "target," "project," "goals," "potential," "predict," "might," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors referred to in the Company's Annual Report on Form 10-K for the year ended December 31, 2014 filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by Momenta from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. Momenta is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
COPAXONE is a registered trademark of Teva Pharmaceuticals. Glatopa is a trademark of Novartis AG.
CONTACT: Investor Relations: Sarah Carmody Momenta Pharmaceuticals 1-617-395-5189 IR@momentapharma.com Media Relations: Karen Sharma MacDougall Biomedical Communications 1-781-235-3060 Momenta@macbiocom.com